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This study has been terminated due to poor accrual
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin + Avastin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | AUC 6 in 250mL saline IV over 30 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita Nanda, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| Oncology Specialists |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboplatin + Avastin | Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboplatin + Avastin | Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | This study has been terminated due to poor accrual. | Posted | Up to 5 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carboplatin + Avastin | Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | General disorders | MedDRA (Unspecified) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rita Nanda | The University of Chicago | 773-834-2756 | rnanda@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
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| bevacizumab |
| Drug |
15mg/kg in 100mL saline IV over 60 - 90 minutes |
|
|
| Up to 5 years |
| Duration of Response | Up to 5 years |
| Correlation of Response to BRCA1 Methylation Status | The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing. | Up to 5 years |
| Park Ridge |
| Illinois |
| 60068 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Response Rate | Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. | This study has been terminated due to poor accrual. | Posted | Up to 5 years |
|
|
| Secondary | Duration of Response | This study has been terminated due to poor accrual. | Posted | Up to 5 years |
|
|
| Secondary | Correlation of Response to BRCA1 Methylation Status | The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing. | This study has been terminated due to poor accrual. | Posted | Up to 5 years |
|
|
| 1 |
| 11 |
| 9 |
| 11 |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| pain | General disorders | MedDRA (Unspecified) |
|
| severe weakness | Nervous system disorders | MedDRA (Unspecified) |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| nausea | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| Chest pain | General disorders | MedDRA (Unspecified) |
|
| Fatigue | General disorders | MedDRA (Unspecified) |
|
| pain | General disorders | MedDRA (Unspecified) |
|
| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) |
|
| Alkaline phosphatase increased | Investigations | MedDRA (Unspecified) |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (Unspecified) |
|
| Creatinine increased | Investigations | MedDRA (Unspecified) |
|
| Ear, nose and throat examination abnormal | Investigations | MedDRA (Unspecified) |
|
| Hemoglobin | Investigations | MedDRA (Unspecified) |
|
| Hemoglobin decreased | Investigations | MedDRA (Unspecified) |
|
| Hyperglycemia | Investigations | MedDRA (Unspecified) |
|
| Laboratory test abnormal | Investigations | MedDRA (Unspecified) |
|
| Leukocytes | Investigations | MedDRA (Unspecified) |
|
| Neutrophil count decreased | Investigations | MedDRA (Unspecified) |
|
| Neutrophils | Investigations | MedDRA (Unspecified) |
|
| Platelet count decreased | Investigations | MedDRA (Unspecified) |
|
| Platelets | Investigations | MedDRA (Unspecified) |
|
| Weight loss | Investigations | MedDRA (Unspecified) |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (Unspecified) |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) |
|
| Proteinuria | Renal and urinary disorders | MedDRA (Unspecified) |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (Unspecified) |
|
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
|
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) |
|
| Hemorrhage - Other (Specify) | Vascular disorders | MedDRA (Unspecified) |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) |
|
| Vascular - Other (Specify) | Vascular disorders | MedDRA (Unspecified) |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |